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Principal Regulatory Affairs Specialist - Robotics Platform

Boston, MA 02133
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Principal Regulatory Affairs Specialist - Robotics Platform


Boston, Massachusetts, United States

Requisition #:


Post Date:

Nov 18, 2020


The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

**MITG's SURGICAL INNOVATIONS** sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

**Careers That Change Lives**

As **Principal Regulatory Affairs Specialist** ,you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you will ensure submissions are accurately prepared and comply with global regulations.

Come strengthen your specialized skills and enhance your expertise. Well help you to expand your expertise with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way thats best for you. Together, we can confront the challenges that will change the face of healthcare.

You must have a track-record of working effectively with teams and developing innovative regulatory strategies for novel electromechanical medical devices.

**A Day in the Life**

The **Principal Regulatory Affairs Specialist** is expected to perform with minimal supervision and is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. In addition, the Principal Specialist mentors other regulatory specialists, and provides support for global regulatory approvals (beyond US and EU), commercialized products, and ensures compliance with Medtronic and government requirements. Your focus will be:

+ Prepare US, EU, and international submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release.

+ Review complex product submissions with manager or other senior management and negotiate submission issues with agency personnel. All significant issues will be reviewed with the manager and/or other senior management.

+ Prepare regulatory strategies/plans and worldwide requirement lists. Provide leadership to product development teams for regulatory issues and questions.

+ Provide business and product information to international regulatory managers to enable development of worldwide strategies and requirements, and communicate that information to business teams. Provide product and test information to major markets to support their local regulatory submissions.

+ Provide support to market-released products as necessary. This includes reviewing labeling, promotional material, product/manufacturing process changes and documentation for changes requiring regulatory approval.

+ Prepare submissions and reports for FDA and support other major market regulatory agencies as required by product status.

+ Develop proficiency in worldwide regulatory requirements and establish and maintain good working relationships with agency personnel

+ Maintain Regulatory Affairs product files to support compliance with regulatory requirements.

**Must Have: Minimum Requirements**

+ Bachelors Degree in science, math or engineering discipline.

+ Minimum 7 years medical device industry experience with 5 years regulatory experience.

+ Or advanced degree with5 years medical device regulatory experience.

**Nice to Have**

+ Advanced degree.

+ R.A.C certification(s).

+ Experience with US De novo and Class III device submissions, including IDE and software-containing devices and medical device capital equipment and IEC 60601-1:2005

+ Minimum US Class II and EU Class IIb device experience and in-depth knowledge of US FDA regulations (Title 21) and EU medical device directive (93/42/EEC) and EU medical device regulations MDR 2017/745.

+ History of successful US 510(k) device submissions, Q-submissions, EU technical files, and experience with regulatory support of clinical trials.

+ Knowledge of GLP/GCP requirements.

+ Excellent negotiation skills.

+ Excellent written/oral communication skills.

+ Thorough knowledge of other regulations pertaining to the legal commercialization of medical devices.

+ Thorough/Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), EU Medical Device Regulation (MDR 2017/745) and ISO 13485:2016

+ Regulatory compliance competency (Inspections, Audits, Field Actions, Quality Systems)

+ International regulatory competency.

+ Clinical trial experience.

+ Proficiency in FDA compliance.

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2020-11-05 Expires: 2021-04-30
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Boston, MA 02133

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